Xisomab 3G3 for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Receiving Chemotherapy

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well xisomab 3G3 works in preventing catheter-associated blood clots (thrombosis) in patients with cancer receiving chemotherapy. Many patients with cancer develop blood clots from their catheters and can have pain, swelling, and other symptoms. They also often require blood thinners, which can increase the risk of bleeding. Xisomab 3G3 is type of drug called a monoclonal antibody that may prevent blood clots caused by a catheter in patients receiving chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborators: National Cancer Institute (NCI); National Heart, Lung, and Blood Institute (NHLBI); Oregon Health and Science University
• Treatments: Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

• Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed

• In consultation with principal investigator (PI) and treating physician, participant's cancer-directed therapy allows for a 1-day period between administration of study drug and subsequent start of planned cancer-directed therapy

• Individuals with a confirmed solid malignancy that are scheduled to undergo insertion of a PICC line or indwelling central venous catheter as part of planned anticancer therapy per institutional standards

• Must have Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• Platelet count > 100 x 10^9/L

• Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Participants of childbearing potential are defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal

• Female participants of childbearing potential must agree to use adequate methods of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year without an alternative medical cause

• Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy

Exclusion Criteria:

• Actively receiving treatment in another therapeutic clinical trial

• Active acute leukemia (lymphoma and myeloma are allowed)

• At time of enrollment, known contraindication to anticoagulation therapy, including:

• Clinically significant active bleeding

• Individual is within 72 hours of major surgery

• Abnormal baseline coagulation tests, including international normalized ratio (INR) > 1.5, or activated partial thromboplastin time (aPTT) prolonged

• Abnormal renal function defined by an estimated glomerular filtration rate (eGFR) < 45 mL/min

• Abnormal hepatic function defined as liver function tests (LFTs) (aspartate aminotransferase [AST], alanine aminotransferase [ALT] or total bilirubin) > 2 x the upper limit of normal or known Child-Pugh class B or C cirrhosis

• Prior history of intracranial hemorrhage

• Primary brain tumors or known brain metastasis

• Major extracranial bleed within the last 6 months where the cause has not been identified or treated

• Known bleeding diathesis

• Use of therapeutic anticoagulation or anti-platelet agents for any indication at enrollment

• At the discretion of the investigator, any other contraindication to anticoagulation therapy

• Presence of a pediatric-sized PICC line

• Participant is expected to receive chemotherapy associated with a 15% or higher incidence of grade 3-4 thrombocytopenia within 14 days of receiving study drug

• Preexisting intravenous catheter, or indwelling spinal or epidural catheter, at time of enrollment that is intended to remain for the duration of study. Participants may remain eligible if existing catheter is to be removed before placement of a catheter for cancer directed therapy. Removal of existing catheter should occur at least 24 hours prior to PICC or indwelling catheter insertion

• Previously documented hypersensitivity to either the drug or excipients

• Psychiatric illness/social situations, or any other condition, that in the opinion of the investigator, would limit compliance with study requirements

• Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 90 days after the last dose of trial treatment

• Participant is allergic to heparin or heparin derivatives

• Participants with a history of venous thromboembolism within the last 3 months